1. ASEAN regional workshop on bilateral Free Trade Agreements Francisco Rossi. IP and access to drugs capacity building project. UNDP - International poverty centre. Brasilia. Brazil. Francisco.rossi@undp-povertycentre.org Lessons from Latin american experience

2. ASEAN Regional workshop on bilateral Free Trade Agreements The stronger the intellectual property rights, the better. The stronger the intellectual property rights, the better. Negotiations with USA = Pharma. Negotiations with USA = Pharma. Lessons from Latin America Lessons from Latin America On impact of IP On impact of IP Next steps Next steps

4. Trips plus measures are totally legal. Trips plus measures are totally legal. Countries on FTA’s believe on IP Countries on FTA’s believe on IP Countries on FTA’s decided sovereignty Countries on FTA’s decided sovereignty FTA’s do not undermine Doha Declaration FTA’s do not undermine Doha Declaration Trips plus is unadequate term; Trips plus is unadequate term; TRIPS PRECISSIONS.

5. Drug makers go furthest to sway Congress By Jim Drinkard, USA TODAY (26/04/05) By the numbers$158 million* Spending in 2004 to lobby the federal government. $17 million Campaign contributions in 2004 to federal candidates (67% to Republicans). $7.3 million Support for the 2004 political party conventions (64% to Republicans). * estimate; Sources: Center for Responsive Politics, Campaign Finance Institute, Center for Public Integrity By the numbers$158 million* Spending in 2004 to lobby the federal government. $17 million Campaign contributions in 2004 to federal candidates (67% to Republicans). $7.3 million Support for the 2004 political party conventions (64% to Republicans). * estimate; Sources: Center for Responsive Politics, Campaign Finance Institute, Center for Public Integrity

6. DIARIO LA REPUBLICA, JUEVES 16 DE SETIEMBRE DEL 2004 DIARIO LA REPUBLICA, JUEVES 16 DE SETIEMBRE DEL 2004.

7. Intellectual Property Rights, Free Trade Agreements and Public Health

9. TRIPS PLUS MEASURES IN RECENT FREE TRADE AGREMENTS APROXIMATE DATE 12/200112/200205/200301/200402/200403/200407/2004JORDANCHILESINGAPORECAFTAAUSTRALIAMOROCCOBAHREIN DATA PROTECTION +++++++ LINKAGES BETWEEN HEALTH REGISTRATION AND PATENTS. LINKAGES BETWEEN HEALTH REGISTRATION AND PATENTS.+++++++ PATENT TERM RESTORATION +++++++ RESTORATION BY REGISTRATION +++++++ ENFORCEMENT+++++++ GENERIC NAME USE RESTRICTIONS. -++++++ PATENTABLE MATTER EXPANSION +---+++ COMPULSORY LICENCES RESTRICTIONS +-+-+-- PARALLEL IMPORTS LIMITATIONS --+-++-

10. Restrictions on INN (generic names) use TRIPS 20 Other Requirements The use of a trademark in the course of trade shall not be unjustifiably encumbered by special requirements, such as use with another trademark, use in a special form or use in a manner detrimental to its capability to distinguish the goods or services of one undertaking from those of other undertakings. This will not preclude a requirement prescribing the use of the trademark identifying the undertaking producing the goods or services along with, but without linking it to, the trademark distinguishing the specific goods or services in question of that undertaking.CAFTA ARTICLE 15.2 TRADEMARKS In view of the obligations of Article 20 of the TRIPS Agreement, each Party shall ensure that provisions mandating the use of the term customary in common language as In view of the obligations of Article 20 of the TRIPS Agreement, each Party shall ensure that provisions mandating the use of the term customary in common language as the common name for a good (“common name”) including, inter alia, requirements concerning the relative size, placement or style of use of the trademark in relation to the common name, do not impair the use or effectiveness of trademarks used in relation to the common name for a good (“common name”) including, inter alia, requirements concerning the relative size, placement or style of use of the trademark in relation to the common name, do not impair the use or effectiveness of trademarks used in relation to such goods. such goods.

11. Intellectual Property Rights, Free Trade Agreements and Public Health Latin American Free Trade Agreements negotiations. Lessons learned.

12. Intellectual Property Rights, Free Trade Agreements and Public Health ON PROCESS USTR: Agreements administrator. USTR: Agreements administrator. Confidentiality Confidentiality U.N. support. Carlos Correa Veto. U.N. support. Carlos Correa Veto. C.S.O. C.S.O. CONGRESS CONGRESS Health sector commitment : relations with trade negotiators Health sector commitment : relations with trade negotiators

14. The agreement is not the end Chilean experience with second uses.

15. Intellectual Property Rights, Free Trade Agreements and Public Health AFTA PROPOSALS AFTA PROPOSALSEverything. Patents for plants, animals, diagnostic, chirurgical and therapeutic methods. Patents for plants, animals, diagnostic, chirurgical and therapeutic methods. Patents for uses Patents for uses C.L. restrictions. C.L. restrictions. National exhaustion of rights National exhaustion of rights AFTA PROPOSALS AFTA PROPOSALSEverything. Patent term restorations. Patent term restorations. Linkage Linkage Data protection Data protection Restriction on generic names Restriction on generic names

16. Intellectual Property Rights, Free Trade Agreements and Public Health AFTA PROPOSALS AFTA PROPOSALS USA PROPOSAL. USA PROPOSAL. ANDEAN PROPOSAL. TRIPS-DOHA ANDEAN PROPOSAL. TRIPS-DOHA 11 ROUNDS. 11 ROUNDS. ANDEAN SECOND PROPOSAL ANDEAN SECOND PROPOSAL DATA PROTECTION DATA PROTECTION TRANSPARENCY TRANSPARENCY PATENT TERM RESTORATION PATENT TERM RESTORATION Colombian IP Negotiator impasse Colombian IP Negotiator impasse Final political decision? Final political decision?

17. IMPACT OF TRIPS PLUS MEASURES. RETROSPECTIVE STUDIES COUNTRYISSUE IMPACT 1 IMPACT 2 REMARKS AMIR ATTARAN AFRICAPATENTSNO POVERTY FEDESARROLLOCOLOMBIA I.P. PRICES NO ENTRY DELAYS IMPORTANT IMPACT OF TRADE MARKS APOYO CONSULTORES PERUFTA CONSUMERS WELFARE 5 M. ONLY ON DATA PROTECTION PUBLIC INSTITUTIONS 1.3M PRICE RISING 94-114% NATIONAL INDUSTRY 2,3M PROSPECTIVE STUDIES COUNTRYISSUE IMPACT 1 IMPACT 2 REMARKS PAHO/IFARMACOLOMBIAFTA DATA 300M 4% 2010 AIDS DEATHS PROSPECTIVE MODEL USES 500M 14% 2014 90/ 2005-4223/2020 PAT REST. 500M 14% 2025 HOUSEHOLDS SPENT ST. 1 - 16% INN REST. 700M 12% 2010 PPU 12% INDECOPIPERUFTA 1182M/YEAR HOUSEHOLDS SPENT INDECOPIPERUFTA 472M DEFICIT 2005 KNOWLEDGE BALANCE 602 M FTA 2015 VALLADARES-MOHPERUFTA PRICE RISING 55-100% TAX EXEMPTION COMPENSATION MEASURES TOTAL SPENT 300 M 1 M/YEAR

20. Fuente: Ramirez M. et al. El gasto en salud de los hogares Colombianos. Universidad del Rosario. 2002.

21. Spent on medicines as a % of income. Households survey. Colombia 1997

22. In developed countries the state pays, in developing the individual!

23. IMPACT OF TRIPS PLUS MEASURES. RETROSPECTIVE STUDIES COUNTRYISSUE IMPACT 1 IMPACT 2 REMARKS AMIR ATTARAN AFRICAPATENTSNO POVERTY FEDESARROLLOCOLOMBIA I.P. PRICES NO ENTRY DELAYS IMPORTANT IMPACT OF TRADE MARKS APOYO CONSULTORES PERUFTA CONSUMERS WELFARE 5 M. ONLY ON DATA PROTECTION PUBLIC INSTITUTIONS 1.3M PRICE RISING 94-114% NATIONAL INDUSTRY 2,3M PROSPECTIVE STUDIES COUNTRYISSUE IMPACT 1 IMPACT 2 REMARKS PAHO/IFARMACOLOMBIAFTA DATA 300M 4% 2010 AIDS DEATHS PROSPECTIVE MODEL USES 500M 14% 2014 90/ 2005-4223/2020 PAT REST. 500M 14% 2025 HOUSEHOLDS SPENT ST. 1 - 16% INN REST. 700M 12% 2010 PPU 12% INDECOPIPERUFTA 1182M/YEAR HOUSEHOLDS SPENT INDECOPIPERUFTA 472M DEFICIT 2005 KNOWLEDGE BALANCE 602 M FTA 2015 VALLADARES-MOHPERUFTA PRICE RISING 55-100% TAX EXEMPTION COMPENSATION MEASURES TOTAL SPENT 300 M 1 M/YEAR

24. IPRC The contemporary evidence suggests that, because developing countries are large net importers of technology from the developed world, the globalisation of IP protection will result in very substantial additional net transfers from developing to developed countries. The contemporary evidence suggests that, because developing countries are large net importers of technology from the developed world, the globalisation of IP protection will result in very substantial additional net transfers from developing to developed countries.www.iprcommission.org

26. Hood Robin

27. The stronger the intellectual property rights, the better. Benefits of innovation: ARV coverage Benefits of innovation: ARV coverage Innovation orientation: Neglected diseases Innovation orientation: Neglected diseases Innovation or stagnation? FDA Report. Innovation or stagnation? FDA Report. Pharmaceutical industry: Research or marketing? Pharmaceutical industry: Research or marketing? IP and development. IP and development. Technology transfer and FDI Technology transfer and FDI

28. IP and access to drugs capacity building project No trips Plus (FTAs.) No trips Plus (FTAs.) National legislation on IP sensitive to public health. (Doha) National legislation on IP sensitive to public health. (Doha) –Full implementation of flexibilities –Full use of P 6 Resolution South – South cooperation on generics South – South cooperation on generics New international IP RULES? New international IP RULES?

31. Spent (US $ million) and people on ARV therapy. Source :MOH – STD/HIV-AIDS National Program. Brazil.

32. LPV.rNFVEFZ12 other ARVs Spent 121 131 106 215 2003 21% 23% 19% 573 37% 3 imported (patented) ARVs mean 63% of total budget. 2003 LPV.r+ EFZ+ NFV 63% 12 other ARVs 37% Source :MOH – STD/HIV-AIDS National Program. Brazil.

33. MS/ 2003 3810 4860 4540 4240 3320 2223 2035 1996199719981999200020012002 Average cost of ARV patient/year 1996 - 2003 1630 2003 Source :MOH – STD/HIV-AIDS National Program. Brazil.